The Statistical Core plays a central role in the functioning of the Immunologic Monitoring Consortium (IMC). Statistical collaboration is required in assay development, comparison, and in the design and execution of the clinical trials that will serve to validate the ability of developed assays to monitor immune responses. The statistical core will work with the administrative core to develop the website to be used as a data repository and will work with each project to perform all the analyses at the pre-clinical and clinical levels. The specific functions of the statistical core are to: (1) assess the reproducibility of the methodologies developed in the four projects and to estimate properties of assay results in volunteers and in cancer patients, (2) assess immune augmentation after immunization, (3) assess the degree of agreement among the four assays, ( 4) provide design and analysis of immunization studies in animals to assess correlation of immune response with anti-tumor activity, and, (5) provide design and analysis of clinical trials of vaccines in cancer patients.